MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X6MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20406

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

Two company representatives were present during an orthognathic surgery (bsso ¿ bilateral sagittal split osteotomy for advancement of the mandible) at the (b)(6).After the osteotomy, repositioning of the segments of the mandible, intermaxillary fixation and final insertion of the bone screws into the upper part of the sliding osteotomy plates (article number 92-15586) and placement of the screws (50-20406) into the slider components for temporary fixation the surgeon intended to perform the final fixation (insertion and final tightening of screws into the screw holes of the lower plate part) at the left side.In the final stage it was observed, that the screw inserted in the sliding component of the plate at the opposite side detached/had loosened.This resulted in a surgical delay of less than 30 minutes, in order to remove the just fixated screws at the left side and the intermaxillary fixation and to redo procedural steps.The screw used for re-fixation of the slider component at the right side was 2.3x8mm (50-23408).The surgeon indicated that he already noted during the insertion and tightening of the screws that they were very smooth-running.This was not expected considering the usual bone quality of patients with this age.The company representatives further stated, that all pilot holes were drilled with the same drill bit (1.5mm twist drill).

• Brand Name: BONE SCREWS, CROSS-PIN, DIAM.2.0X6MM, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5524354
• MDR Text Key: 41419682
• Report Number: 0008010177-2016-00054
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 50-20406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1